TY - JOUR
AU - Wicherski, Julia
AU - Peltner, Jonas
AU - Becker, Cornelia
AU - Schüssel, Katrin
AU - Brückner, Gabriela
AU - Schlotmann, Andreas
AU - Schröder, Helmut
AU - Kern, Winfried V
AU - Haenisch, Britta
TI - High risk for life-threatening adverse events of fluoroquinolones in young adults: a large German population-based cohort study.
JO - BMC medicine
VL - 23
IS - 1
SN - 1741-7015
CY - London
PB - BioMed Central
M1 - DZNE-2025-00307
SP - 76
PY - 2025
AB - Fluoroquinolone antibiotics have a high potential for serious adverse drug reactions, but real-world evidence in European patient cohorts is lacking. Therefore, we aim to examine the association between fluoroquinolone exposure and potentially life-threatening adverse events stratified by age and gender in Germany.We conducted an administrative cohort study using the active comparator new user design with a risk window up to 365 days between January 2013 and December 2019. Population-based longitudinal data from one of the largest German statutory health insurances were used. Episodes of newly dispensed fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, and enoxacin) were compared to other antibiotics (amoxicillin, amoxicillin clavulanic acid, azithromycin, cefuroxime, cephalexin, clindamycin, sulfamethoxazole-trimethoprim, and doxycycline). Endpoints were defined by incident diagnoses of aortic aneurysm/dissection, cardiac arrhythmia, hepatotoxicity, and all-cause mortality. Adjusted hazard ratios were estimated from piece-wise exponential additive mixed models with smooth non-linear effects for person-time and age and adjusted for comorbidities, year and quarter at index.The cohorts comprised 15,139,840; 11,760,159; 11,027,175; and 15,305,757 antibiotic episodes. Patients during fluoroquinolone episodes were older (59 versus 51 years) and more often female (58
KW - Humans
KW - Germany: epidemiology
KW - Female
KW - Male
KW - Fluoroquinolones: adverse effects
KW - Adult
KW - Middle Aged
KW - Anti-Bacterial Agents: adverse effects
KW - Aged
KW - Cohort Studies
KW - Young Adult
KW - Arrhythmias, Cardiac: chemically induced
KW - Arrhythmias, Cardiac: epidemiology
KW - Aortic Dissection: epidemiology
KW - Aortic Dissection: chemically induced
KW - Chemical and Drug Induced Liver Injury: epidemiology
KW - Chemical and Drug Induced Liver Injury: etiology
KW - Adolescent
KW - Drug-Related Side Effects and Adverse Reactions: epidemiology
KW - Age Factors
KW - Risk Factors
KW - Adverse drug reactions (Other)
KW - Antibiotics (Other)
KW - Cohort study (Other)
KW - Fluoroquinolones (Other)
KW - Real-world evidence (Other)
KW - Fluoroquinolones (NLM Chemicals)
KW - Anti-Bacterial Agents (NLM Chemicals)
LB - PUB:(DE-HGF)16
C6 - pmid:39920723
C2 - pmc:PMC11806691
DO - DOI:10.1186/s12916-025-03919-0
UR - https://pub.dzne.de/record/276749
ER -